AR102101A2 - FORMULATION AND METHOD OF ARIPIPRAZOL COMPLEX - Google Patents

FORMULATION AND METHOD OF ARIPIPRAZOL COMPLEX

Info

Publication number
AR102101A2
AR102101A2 ARP150103114A ARP150103114A AR102101A2 AR 102101 A2 AR102101 A2 AR 102101A2 AR P150103114 A ARP150103114 A AR P150103114A AR P150103114 A ARP150103114 A AR P150103114A AR 102101 A2 AR102101 A2 AR 102101A2
Authority
AR
Argentina
Prior art keywords
cyclodextrin
formulation
aripiprazole
complex
sbecd
Prior art date
Application number
ARP150103114A
Other languages
Spanish (es)
Inventor
Dominick Mark
Naringrekar Vijay
Nerurkar Manoj
Original Assignee
Otsuka Pharma Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=31946748&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR102101(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Otsuka Pharma Co Ltd filed Critical Otsuka Pharma Co Ltd
Publication of AR102101A2 publication Critical patent/AR102101A2/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/724Cyclodextrins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B82NANOTECHNOLOGY
    • B82YSPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nanotechnology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Se proporciona una formulación de aripiprazol que incluye un agente antisicótico en la forma de un complejo de inclusión en una b-ciclodextrina, preferiblemente b-ciclodextrina de éter sulfobutilo (SBECD), que en la forma de un inyectable produce generalmente reversible irritación mínima a moderada en el sitio de inyección intramuscular. Se proporciona un método para minimizar o reducir la irritación causada por el aripiprazol en un sitio de inyección intramuscular y un método para tratar esquizofrenia mediante el empleo de la formulación anterior. Reivindicación 1: Un complejo de inclusión de aripiprazol en una b-ciclodextrina. Reivindicación 2: El complejo como se definió en la reivindicación 1 en donde la b-ciclodextrina es b-ciclodextrina de éter sulfobutilo (SBECD) o hidroxipropil-b-ciclodextrina (HPBCD). Reivindicación 18: La formulación como se definió en la reivindicación 11 que comprende aripiprazol en una cantidad para proveer de aproximadamente 1.5 a aproximadamente 8 mg/mL de formulación, SBECD en una cantidad en la escala de 100 a aproximadamente 200 mg/mL; ácido tartárico en una cantidad dentro de la escala de aproximadamente 7 a aproximadamente 9 mg/mL de hidróxido de sodio cs para ajustar el pH dentro de la escala de aproximadamente 4 a aproximadamente 4.6 y agua cs para 1 mL.A formulation of aripiprazole is provided that includes an antisychotic agent in the form of an inclusion complex in a b-cyclodextrin, preferably sulfobutyl ether b-cyclodextrin (SBECD), which in the form of an injectable generally produces minimal to moderate irritation. at the intramuscular injection site. A method is provided to minimize or reduce the irritation caused by aripiprazole at an intramuscular injection site and a method to treat schizophrenia by using the above formulation. Claim 1: An inclusion complex of aripiprazole in a b-cyclodextrin. Claim 2: The complex as defined in claim 1 wherein the b-cyclodextrin is sulfobutyl ether b-cyclodextrin (SBECD) or hydroxypropyl-b-cyclodextrin (HPBCD). Claim 18: The formulation as defined in claim 11 comprising aripiprazole in an amount to provide about 1.5 to about 8 mg / mL of formulation, SBECD in an amount on the scale of 100 to about 200 mg / mL; Tartaric acid in an amount within the range of about 7 to about 9 mg / mL of sodium hydroxide cs to adjust the pH within the range of about 4 to about 4.6 and water cs for 1 mL.

ARP150103114A 2002-08-20 2015-09-28 FORMULATION AND METHOD OF ARIPIPRAZOL COMPLEX AR102101A2 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US40471302P 2002-08-20 2002-08-20

Publications (1)

Publication Number Publication Date
AR102101A2 true AR102101A2 (en) 2017-02-01

Family

ID=31946748

Family Applications (2)

Application Number Title Priority Date Filing Date
AR20030102990A AR040887A1 (en) 2002-08-20 2003-08-19 FORMULATION AND METHOD OF ARIPIPRAZOL COMPLEX
ARP150103114A AR102101A2 (en) 2002-08-20 2015-09-28 FORMULATION AND METHOD OF ARIPIPRAZOL COMPLEX

Family Applications Before (1)

Application Number Title Priority Date Filing Date
AR20030102990A AR040887A1 (en) 2002-08-20 2003-08-19 FORMULATION AND METHOD OF ARIPIPRAZOL COMPLEX

Country Status (32)

Country Link
US (8) US7115587B2 (en)
EP (1) EP1542668B1 (en)
JP (1) JP4729306B2 (en)
KR (1) KR101043866B1 (en)
CN (1) CN100335047C (en)
AR (2) AR040887A1 (en)
AT (1) ATE428423T1 (en)
AU (1) AU2003269965B2 (en)
BR (1) BR0313602A (en)
CA (1) CA2495864C (en)
CY (1) CY1110331T1 (en)
DE (1) DE60327225D1 (en)
DK (1) DK1542668T3 (en)
ES (1) ES2322953T3 (en)
GE (1) GEP20063996B (en)
HR (1) HRP20050149B1 (en)
IL (1) IL166623A (en)
IS (1) IS2878B (en)
MX (1) MXPA05001865A (en)
MY (1) MY140793A (en)
NO (1) NO333458B1 (en)
NZ (1) NZ537995A (en)
PE (1) PE20040895A1 (en)
PL (1) PL212428B1 (en)
PT (1) PT1542668E (en)
RS (1) RS51903B (en)
RU (1) RU2342931C2 (en)
SI (1) SI1542668T1 (en)
TW (1) TWI307626B (en)
UA (1) UA79984C2 (en)
WO (1) WO2004017897A2 (en)
ZA (1) ZA200501064B (en)

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Also Published As

Publication number Publication date
US20040077594A1 (en) 2004-04-22
IL166623A0 (en) 2006-01-15
US20150328335A1 (en) 2015-11-19
IS7701A (en) 2005-02-18
US20060234979A1 (en) 2006-10-19
IS2878B (en) 2014-04-15
CA2495864A1 (en) 2004-03-04
US20140235574A1 (en) 2014-08-21
ES2322953T3 (en) 2009-07-02
US20120053145A1 (en) 2012-03-01
RU2342931C2 (en) 2009-01-10
RS20050118A (en) 2007-06-04
KR101043866B1 (en) 2011-06-22
PL212428B1 (en) 2012-09-28
TWI307626B (en) 2009-03-21
US20130045981A1 (en) 2013-02-21
RS51903B (en) 2012-02-29
TW200405813A (en) 2004-04-16
BR0313602A (en) 2005-06-21
US20110160224A1 (en) 2011-06-30
DK1542668T3 (en) 2009-07-20
US8999952B2 (en) 2015-04-07
MY140793A (en) 2010-01-15
CN1674882A (en) 2005-09-28
AU2003269965B2 (en) 2008-02-21
NZ537995A (en) 2007-11-30
SI1542668T1 (en) 2009-08-31
CA2495864C (en) 2011-09-27
CN100335047C (en) 2007-09-05
KR20050040927A (en) 2005-05-03
PE20040895A1 (en) 2004-11-20
RU2005107471A (en) 2005-09-10
JP2006501240A (en) 2006-01-12
US7550445B2 (en) 2009-06-23
ZA200501064B (en) 2006-12-27
IL166623A (en) 2011-07-31
EP1542668A4 (en) 2007-10-17
WO2004017897A3 (en) 2004-12-02
US7115587B2 (en) 2006-10-03
HRP20050149A2 (en) 2005-10-31
CY1110331T1 (en) 2015-01-14
MXPA05001865A (en) 2005-06-03
EP1542668B1 (en) 2009-04-15
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JP4729306B2 (en) 2011-07-20
UA79984C2 (en) 2007-08-10
NO333458B1 (en) 2013-06-10
PL374798A1 (en) 2005-10-31
AU2003269965A1 (en) 2004-03-11
PT1542668E (en) 2009-06-09
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GEP20063996B (en) 2006-12-11
WO2004017897A2 (en) 2004-03-04
NO20050661L (en) 2005-03-16
US20090186903A1 (en) 2009-07-23
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AR040887A1 (en) 2005-04-20
HRP20050149B1 (en) 2014-09-12

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